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Biguanide

Metformin for Pre-eclampsia Prevention in Type 1 Diabetes

Phase 4
Recruiting
Led By Maisa N Feghali, MD
Research Sponsored by Maisa N. Feghali, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosed with type 1 DM prior to pregnancy.
Pregnant women 18-50 years 12 0/7 and 19 6/7 weeks of gestation
Must not have
Medical comorbidities that increase risk for metformin use: renal insufficiency (creatinine > 1.1 mg/dL), proteinuria (P:C >0.3 or 24-hour urine protein > 300 mg), active liver disease (acute hepatitis, chronic active hepatitis, persistently abnormal liver enzymes 3x above normal), inflammatory bowel disease (Crohn's and Ulcerative colitis), major hematologic disorder (including alloimmune and isoimmune thrombocytopenia).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial

Summary

This trial will test whether metformin can help prevent hypertensive disorders of pregnancy in women with type 1 diabetes.

Who is the study for?
This trial is for pregnant women aged 18-50 with type 1 diabetes, between 12 and just under 20 weeks of gestation. It's not suitable for those with multiple pregnancies, kidney issues, significant protein in urine, liver disease, inflammatory bowel disease, major blood disorders or known metformin allergies.
What is being tested?
The study tests if taking metformin before the 20th week of pregnancy can reduce high blood pressure-related complications compared to usual care in women with type 1 diabetes. Metformin is a medication typically used to manage diabetes and has been shown safe outside pregnancy.
What are the potential side effects?
Metformin may cause side effects like nausea, diarrhea, stomach pain and loss of appetite. Rarely it could lead to a serious condition called lactic acidosis especially if there are kidney problems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I was diagnosed with type 1 diabetes before becoming pregnant.
Select...
I am pregnant, between 18 to 50 years old, and in my second trimester.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I do not have severe kidney, liver, bowel, or major blood disorders.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2015 Phase 4 trial • 156 Patients • NCT02002221
13%
Nasopharyngitis
10%
Hyperhidrosis
9%
Hunger
9%
Tremor
8%
Asthenia
6%
Hypoglycaemia
1%
Femoral neck fracture
1%
Squamous cell carcinoma of the tongue
100%
80%
60%
40%
20%
0%
Study treatment Arm
Vildagliptin (LAF237)
Placebo

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: MetforminExperimental Treatment1 Intervention
Group II: Usual careActive Control1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Metformin
2006
Completed Phase 4
~2430

Find a Location

Who is running the clinical trial?

Maisa N. Feghali, MDLead Sponsor
2 Previous Clinical Trials
67 Total Patients Enrolled
Maisa N Feghali, MDPrincipal InvestigatorUniversity of Pittsburgh
2 Previous Clinical Trials
54 Total Patients Enrolled

Media Library

Metformin (Biguanide) Clinical Trial Eligibility Overview. Trial Name: NCT03570632 — Phase 4
Gestational Diabetes Research Study Groups: Usual care, Metformin
Gestational Diabetes Clinical Trial 2023: Metformin Highlights & Side Effects. Trial Name: NCT03570632 — Phase 4
Metformin (Biguanide) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03570632 — Phase 4
~0 spots leftby Dec 2024
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